{"id":23977,"date":"2023-07-07T11:25:09","date_gmt":"2023-07-07T09:25:09","guid":{"rendered":"https:\/\/idibell.cat\/?p=23977"},"modified":"2023-07-07T11:29:46","modified_gmt":"2023-07-07T09:29:46","slug":"la-unitat-dinvestigacio-clinica-en-assaigs-clinics-aconsegueix-la-recertificacio-iso-90012015-2","status":"publish","type":"post","link":"https:\/\/idibell.cat\/2023\/07\/la-unitat-dinvestigacio-clinica-en-assaigs-clinics-aconsegueix-la-recertificacio-iso-90012015-2\/","title":{"rendered":"La Unitat d\u2019Investigaci\u00f3 Cl\u00ednica en Assaigs Cl\u00ednics aconsegueix la recertificaci\u00f3 ISO 9001:2015"},"content":{"rendered":"<p>La Unitat d\u2019Investigaci\u00f3 Cl\u00ednica en Assaigs Cl\u00ednics (UICEC) de l\u2019IDIBELL, gestionada pel servei de Farmacologia Cl\u00ednica de l\u2019HUB i liderada per la cap d\u2019aquest servei, la Dra. Pilar Hereu, ha aconseguit la recertificaci\u00f3 del seu sistema de gesti\u00f3 de la qualitat. L&#8217;acreditaci\u00f3 es va obtenir per primera vegada l&#8217;any 2021 i requereix una revisi\u00f3 anual per verificar que es mantenen els requisits necessaris.<\/p>\n<p>A trav\u00e9s de l\u2019entitat de certificaci\u00f3 Applus+ i segons la <strong>norma ISO 9001:2015<\/strong>, la de major reconeixement en l\u2019\u00e0mbit mundial en gesti\u00f3 de qualitat, la UICEC ha aconseguit la renovaci\u00f3 de la certificaci\u00f3 gr\u00e0cies a refermar els seus processos de qualitat. El sistema de gesti\u00f3 de la qualitat de la UICEC ha estat implementat amb l\u2019acompanyament de <a href=\"https:\/\/idibell.cat\/serveis\/suport-de-gestio\/qualitat-i-gestio-del-coneixement\/\">la Unitat de Qualitat<\/a> de l\u2019IDIBELL.<\/p>\n<p>Aquesta recertificaci\u00f3 s\u2019ha superat sense detectar cap no-conformitat. El reconeixement suposa una <strong>garantia de qualitat<\/strong> dels serveis de la UICEC i inclou els processos de gesti\u00f3 i coordinaci\u00f3 de projectes, gesti\u00f3 administrativa i tramitaci\u00f3 del projecte, monitoritzaci\u00f3 i \u00a0la farmacovigil\u00e0ncia de l\u2019assaig cl\u00ednic.<\/p>\n<p>La UICEC ofereix suport als grups d\u2019investigaci\u00f3 cl\u00ednica del Campus Bellvitge per a la realitzaci\u00f3 d\u2019estudis de recerca cl\u00ednica, especialment els assaigs cl\u00ednics en diverses \u00e0rees terap\u00e8utiques. Presta serveis als investigadors en l\u2019exercici de les seves responsabilitats com a promotors independents.<\/p>\n<p>En depend\u00e8ncia funcional del Servei de Farmacologia Cl\u00ednica de l\u2019HUB, la UICEC forma part de la <a href=\"https:\/\/www.scren.eu\/\">Plataforma SCReN (Spanish Clinical Research Network)<\/a> de <a href=\"https:\/\/www.isciii.es\/Paginas\/Inicio.aspx\">l\u2019Instituto de Investigaci\u00f3n Carlos III<\/a> (ISCIII) (PT20\/00008) i de la xarxa europea ECRIN (<a href=\"https:\/\/ecrin.org\/\">European Clinical Research Infrastructure Network<\/a><em>). <\/em><\/p>\n<p>La reacreditaci\u00f3 ISO 9001:2015 de la UICEC de l\u2019IDIBELL ha de permetre mantenir la qualitat en la seva prestaci\u00f3 de serveis, aix\u00ed com millorar la seva oferta i internacionalitzaci\u00f3.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Activitat de la UICEC en el darrer any <\/strong><\/p>\n<p>La UICEC mant\u00e9 un creixement sostingut de la seva activitat en els darrers anys. En concret, aquest 2022 ha prestat serveis a 46 assaigs cl\u00ednics actius, majorit\u00e0riament assaigs cl\u00ednics amb medicaments, 15 dels quals son assaigs cl\u00ednics de la xarxa SCReN. En els darrers anys, la Unitat ha millorat la seva internacionalitzaci\u00f3 i ha donat suport a 8 assaigs cl\u00ednics internacionals, dels quals 3 compten amb finan\u00e7ament de la convocat\u00f2ria H2020 i suport d\u2019ECRIN.<\/p>\n<p>La UICEC va fer la tasca de posar en marxa els assaigs cl\u00ednics independents de terap\u00e8utica en la infecci\u00f3 pel SARS-CoV-2, i actualment d\u00f3na suport a assaigs cl\u00ednics internacionals del consorci europeu <a href=\"https:\/\/vaccelerate.eu\/\">Vaccelerate<\/a>, que avalua estrat\u00e8gies terap\u00e8utiques amb vacunes contra la COVID-19.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><em>L\u2019Institut d&#8217;Investigaci\u00f3 Biom\u00e8dica de Bellvitge (IDIBELL) \u00e9s un centre de recerca en biomedicina creat l\u2019any 2004. Est\u00e0 participat per l&#8217;Hospital Universitari de Bellvitge i l\u2019Hospital de Viladecans de l&#8217;Institut Catal\u00e0 de la Salut, l&#8217;Institut Catal\u00e0 d&#8217;Oncologia, la Universitat de Barcelona i l\u2019Ajuntament de l\u2019Hospitalet de Llobregat.<\/em><\/p>\n<p><em>L\u2019IDIBELL \u00e9s membre del Campus d&#8217;Excel\u00b7l\u00e8ncia Internacional de la Universitat de Barcelona HUBc i forma part de la instituci\u00f3 CERCA de la Generalitat de Catalunya. L&#8217;any 2009 es va convertir en un dels cinc primers centres d\u2019investigaci\u00f3 espanyols acreditats com a institut d\u2019investigaci\u00f3 sanit\u00e0ria per l\u2019Instituto de Salud Carlos III. A m\u00e9s, forma part del programa \u201cHR Excellence in Research\u201d de la Uni\u00f3 Europea i \u00e9s membre de EATRIS i REGIC. Des de l\u2019any 2018, l\u2019IDIBELL \u00e9s un Centro Acreditado de la Fundaci\u00f3n Cient\u00edfica AECC (FCAECC).<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>L&#8217;acreditaci\u00f3 es va obtenir per primera vegada l&#8217;any 2021 i requereix una revisi\u00f3 anual per verificar que es mantenen els requisits necessaris.<\/p>\n","protected":false},"author":8,"featured_media":23983,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[1],"tags":[],"class_list":["post-23977","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sin-categorizar"],"publishpress_future_action":{"enabled":false,"date":"2024-12-29 11:16:13","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category"},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/posts\/23977","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/comments?post=23977"}],"version-history":[{"count":1,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/posts\/23977\/revisions"}],"predecessor-version":[{"id":23978,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/posts\/23977\/revisions\/23978"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/media\/23983"}],"wp:attachment":[{"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/media?parent=23977"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/categories?post=23977"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/idibell.cat\/wp-json\/wp\/v2\/tags?post=23977"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}